FDA.reportPublic FDA data

Tranquil-C™

Primary DI
B678822457CT10
Brand
Tranquil-C™
Company
NEXUS SPINE, L.L.C.
Model
822457CT1
Device description
Cervical Trial +DS 10x16x13 Lordotic – No DS
Published
2021-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTemplate
LXHOrthopedic Manual Surgical Instrument
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170297000Tranquil Interbody SystemNexus Spine, LLC2017-06-27MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678822457CT1Direct MarkingHIBCC0
B678822457CT10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Millimeter
Length13Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B678520147S0PressON520147S2026-07-08
B6785201460PressON™5201462021-12-17
B6785251540Stable-L™5251542024-05-01
B678525154S0Stable-L™525154S2024-05-01
B678525155S0Stable-L™525155S2024-05-01
B678525156S0Stable-L™525156S2024-05-01
B678525157S0Stable-L™525157S2024-05-01
B678525158S0Stable-L™525158S2024-05-01
B6785251590Stable-L™5251592024-05-01
B678525159S0Stable-L™525159S2024-05-01
B6785251600Stable-L™5251602024-05-01
B678525160S0Stable-L™525160S2024-05-01
B6785251610Stable-L™5251612024-05-01
B678525161S0Stable-L™525161S2024-05-01
B6785251620Stable-L™5251622024-05-01
B678525162S0Stable-L™525162S2024-05-01
B6785251630Stable-L™5251632024-05-01
B678525163S0Stable-L™525163S2024-05-01
B6785251640Stable-L™5251642024-05-01
B678525164S0Stable-L™525164S2024-05-01

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00840286855587TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855921TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859929TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859943TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859967TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859974TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859981TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859998TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860000TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
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00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
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00840286860130Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
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00840286860505Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
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00840286860543Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
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00840286860604Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09